US20060229491A1 - Method for treating myocardial rupture - Google Patents
Method for treating myocardial rupture Download PDFInfo
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- US20060229491A1 US20060229491A1 US11/199,633 US19963305A US2006229491A1 US 20060229491 A1 US20060229491 A1 US 20060229491A1 US 19963305 A US19963305 A US 19963305A US 2006229491 A1 US2006229491 A1 US 2006229491A1
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Definitions
- the expansive strand or strands are formed from material which is stiffer than the flexible, unsupported material of the membrane to provide an outward expansive force or thrust to prevent formation of undesirable inwardly directed folds or wrinkles when the ribs of the partitioning device are in a contracted configuration.
- Suitable strand or strands are formed from materials such as polypropylene suture or supereleastic NiTi alloy wires. Such strands are typically about 0.005 to about 0.03 inch (about 0.13 to about 0.76 mm) in diameter to provide the requisite outward expansive force when placed in a circular position such as around the periphery of the membrane in less than completely expanded configuration.
- FIG. 2B is a schematic view of the patient's heart of FIG. 2A with a left ventricular chamber tamponade.
- FIG. 2C is a schematic view of the patient's heart of FIG. 2B after treatment according to a method of the present invention.
- FIG. 14 is a schematic view of the patient's heart after treatment according to a method of the present invention utilizing a device embodying features of the present invention having an reinforced membrane with an eccentric peripheral base.
- FIG. 2A is a schematic illustration of the patient's heart 10 showing the right ventricle 11 and the left ventricle 12 with the mitral valve 13 and aortic valve 14 .
- FIG. 9 illustrates the curved free proximal ends 37 of ribs 34 which are provided with sharp tip elements 48 configured to engage, and preferably penetrate into, the wall of the heart chamber and hold the partitioning device 30 in a deployed position within the patient's heart chamber so as to partition the ventricular chamber into a productive portion and a non-productive portion, as described above with reference to FIGS. 1A-1C and 2 A- 2 C.
- the free proximal ends 37 thereof expand to a desired angular displacement, away from the centerline axis 38 , of about 20° (degree) to about 90°, preferably about 50° to about 80°.
- the unconstrained diameter of the partitioning device 30 is preferably greater than the diameter of the heart chamber at the deployed location of the partitioning device so that an outward force is applied to the wall of the heart chamber by the at least partially expanded ribs 34 during systole and diastole so that the resilient frame 33 augments the heart wall movement.
- a balloon inflation port 73 preferably proximal to the rotating knob 72 , is in fluid communication with the inner lumen 68 of the torque shaft 67 .
- FIG. 14 illustrates an alternative design which embodies features of a device usable in practicing methods having features of the present invention, in which the partitioning device 30 ′ is provided with an eccentric-shaped membrane 31 ′ which is well suited for treating VSD lesions that may occur further up (more proximal) the ventricular septum because of the different anatomical features and physiologic action of the ventricular septum versus the anterior free wall.
- the septal wall primarily moves in and out only, relative to the chamber, versus the free wall that has a rotation component to its excursion.
- the outflow track which comprises the upper half of the ventricular septal wall below the aortic valve has very little or no trebeculation.
- the device is shown with a nubbin foot 45 ′ (and not the extended stem foot) allowing the device to sit more distally and intimately with the apex.
Abstract
Description
- The present invention relates generally to the field of treating heart disease, particularly schemic coronary disease, and more specifically, to a method for partitioning a patient's heart chamber having a myocardial rupture or exhibiting characteristics of an incipient rupture.
- An acute myocardial infarction (AMI) may lead to myocardial rupture. Myocardial rupture may also occur as a result of blunt and penetrating cardiac trauma, primary cardiac infection, primary and secondary cardiac tumors, infiltrative diseases of the heart, and aortic dissection. Mortality rates are extremely high unless early diagnosis and surgical intervention are provided rapidly. The consequences of myocardial rupture in the setting of AMI can be cardiac pericardial tamponade, ventricular septal defect (VSD), acute mitral regurgitation (MR), or formation of a pseudoaneurysm.
- Cardiac tamponade is a clinical syndrome caused by the accumulation of fluid in the pericardial space, resulting in reduced ventricular filling and subsequent hemodynamic compromise. Cardiac tamponade is a medical emergency. The overall risk of death depends on the speed of diagnosis, the treatment provided, and the underlying cause of the tamponade.
- The pericardium, which is the membrane surrounding the heart, is comprised of two layers. The parietal pericardium is the outer fibrous layer and the visceral pericardium is the inner serous layer with the pericardial spaced formed therebetween. The pericardial space normally contains 20-50 mL of fluid. Pericardial effusions can be serous, serosanguineous, hemorrhagic, or chylous.
- The hemodynamic changes in the case of cardiac tamponade have been described to include three phases. Phase one involves the accumulation of pericardial fluid causing increased stiffness of the ventricle, requiring a higher filling pressure. In phase two fluid further accumulates resulting in reduced cardiac output. In phase three the pericardial and left ventricular (LV) filling pressures equilibrate, resulting in further decrease in cardiac output.
- The development of tamponade may result in diminished diastolic filling as well as altered systemic venous return, both of which may result in reduced cardiac output.
- Additionally, mechanical assist devices have been developed as intermediate procedures for treating patients in cardiogenic shock resulting from tamponade. Such devices include left ventricular assist devices and total artificial hearts. A left ventricular assist device includes a mechanical pump for increasing blood flow from the left ventricle into the aorta. Total artificial heart devices, such as the Jarvik heart, are usually used only as temporary measures while a patient awaits surgical repair of the lesion.
- Surgical therapies for a hemodynamically unstable patient or one with recurrent tamponade include procedures such as pericardial centesis or surgical creation of a pericardial window involving open thoracotomy and/or pericardiotomy; creation of a pericardio-peritoneal shunt, and resection of the infarcted area and closure of the rupture zone with Teflon or Dacron patches or with the use of biological glues, are among the recommended surgical therapies. For a patient with a ventricular septal defect (VSD), surgical therapies include by directly closing or replacing of a patch, similar to treatment of tamponade. These procedures are highly invasive, risky and expensive and are commonly only done in conjunction with other procedures (such as heart valve replacement or coronary artery by-pass graft).
- The present invention is directed to a method for the treatment of a patient's heart which has a myocardial rupture, and or stabilizing a traumatic rupture through the heart wall (e.g., stab wound).
- A myocardial infraction, (MI), may result in myocardial ruptures leading to pericardial tamponade, VSD, acute mitral regurgitation (MR), or formation of a pseudoaneurysm. The present method is directed to treating a patient's heart having such a rupture (partial or complete); and/or an incipient rupture. The method includes separating the weakened or failed region to minimize the size and/or the effects of such a rupture or opening. The present method at least partially restores of the hemodynamic competency of the chamber of the patient's heart which has or will soon have a rupture.
- The amount of pericardial fluid needed to impair the diastolic filling of the heart depends on the rate of fluid accumulation and the compliance of the pericardium. Rapid accumulation of fluid may have a much greater impact on increasing the pericardial pressure, thus severely impeding cardiac output, than fluid accumulation over a longer period. The method device of the present invention, moreover, improves the diastolic function of the patient's heart.
- In particular, the method of the present invention includes partitioning a chamber (e.g., left or/or right ventricles) of the patient's heart into a main productive portion and a secondary non-productive portion which has a rupture or which exhibits the characteristics of an incipient rupture. This partitioning closes off the portion of the heart having the rupture or incipient rupture to prevent loss of blood from the chamber and to reduce the total volume of the heart chamber and thereby reducing the stress applied to weakened tissue of the patient's heart wall. As a result, the ejection fraction of the chamber is improved.
- One method embodying features of the invention includes the use of a partitioning device having a partitioning membrane, preferably a reinforced partitioning device, with a, pressure receiving surface, preferably concave, which defines in part the main productive portion of the partitioned heart chamber when disposed, preferably securely, within the patient's heart chamber.
- The pressure receiving surface is preferably formed from a flexible membrane that is preferably reinforced by a radially expandable frame component formed of a plurality of ribs. The ribs of the expandable frame have proximal ends which are preferably free, and distal ends which are preferably secured to a central hub to facilitate radial self expansion of the free proximal ends of the ribs away from a centerline axis. The distal ends of the ribs may be pivotally mounted to the hub and biased outwardly or fixed to the hub. The ribs are preferably formed from material such as superelastic NiTi alloy which allows for compressing the free proximal ends of the ribs toward the centerline axis and into a contracted configuration for delivery and self expansion when released for deployment upon release within the patient's heart chamber. The membrane may be of variable shape suitable to practice the present invention and aid in the treatment of the MI. In one embodiment the membrane has an eccentric shape to more particularly be configured for use in the upper portions of the ventricular septum.
- The free proximal ends of the ribs are configured to engage, and preferably penetrate into, the tissue lining of the targeted heart chamber (i.e., heart chamber to be partitioned). The engagement, preferably penetration, of the proximal ends with the tissue lining of the heart chamber, enables the securing of a peripheral edge of the partitioning device to the heart wall and fixation of the partitioning device within the chamber so as to partition the chamber in a desired manner. Preferably, tissue penetrating proximal tips of the free proximal ends are configured to penetrate the tissue lining at an angle approximately perpendicular to the centerline axis of the partitioning device. The tissue penetrating proximal tips of the ribs may be provided with barbs, hooks and the like which prevent undesired withdrawal of the tips from the heart wall.
- In another embodiment having features of the invention, an expansive member such as one or more strands and/or swellable pads extend between at least one pair of adjacent ribs at or close to an outer edge or periphery of the membrane to exert enough pressure to the flexible membrane periphery when the partitioning device is in an expanded configuration to provide an adequate seal between the membrane periphery and the lining of the heart wall. In one embodiment, a single strand or strands extend around essentially the entire periphery of the membrane so that the flexible periphery of the membrane between each pair of ribs is effectively sealed against the heart wall. The expansive strand or strands are formed from material which is stiffer than the flexible, unsupported material of the membrane to provide an outward expansive force or thrust to prevent formation of undesirable inwardly directed folds or wrinkles when the ribs of the partitioning device are in a contracted configuration. Suitable strand or strands are formed from materials such as polypropylene suture or supereleastic NiTi alloy wires. Such strands are typically about 0.005 to about 0.03 inch (about 0.13 to about 0.76 mm) in diameter to provide the requisite outward expansive force when placed in a circular position such as around the periphery of the membrane in less than completely expanded configuration.
- In another embodiment expandable pads are provided between each adjacent pair of ribs which are configured to swell upon contact with body fluids to provide an outward expansive force or thrust, as described above, to prevent formation of inwardly directed folds or wrinkles when the ribs of the portioning device are in at least a partially contracted configuration. Preferably, the pads are formed from expansive hydrophilic foam. Suitable swellable materials include collagen, gelatin, polylactic acid, polyglycolic acid, copolymers of polylactic acid and polyglycolic acid, polycaprolactone, and mixtures and copolymers thereof. Other suitable swellable bioresorbable polymeric materials may be employed. The expandable pads may also be formed so as to deliver a variety of therapeutic or diagnostic agents.
- The ribs in their expanded configuration angle outwardly from the hub and the free proximal ends curve outwardly so that the membrane is secured to the ribs of the expanded frame forming a trumpet-shaped, pressure receiving surface.
- The partitioning membrane in the expanded configuration generally has radial dimension from about 10 to about 160 mm, preferably from about 50 to about 100 mm, as measured from the centerline axis. The membrane is preferably formed from flexible material or fabric such as expanded polytetrafluoroethylene (ePTFE).
- In an embodiment, the partitioning device is designed to be oversized with respect to the chamber in which it is to be deployed so that the ribs of the device are under compression so that they can apply an outward force against the chamber wall. When the partitioning device is collapsed for delivery, the outwardly biased strand or strands ensure that there are no inwardly directed folds or wrinkles and that none are formed when the partitioning device is expanded for deployment within the heart chamber.
- In one partitioning device design useful in the practice of the methods of the present invention, the free ends of the expansive strand or strands may be secured together and/or to the partitioning device. Alternatively, in another device design, the expansive strand or strands may be sufficiently long so that one or both free ends thereof extend out of the patient to facilitate collapse and retrieval of the partitioning device, if so desired. Pulling on the free ends of the strand extending out of the patient closes the expanded portion, i.e. the ribs and membrane, of the partitioning device to collapse the device as well as retrieving the collapsed partitioning device into an inner lumen of a guide catheter or other collecting device such as that described in co-pending application filed concurrently herewith entitled “Peripheral Seal for a Ventricular Partitioning Device”, assigned to the assignee of the present invention, and incorporated herein by reference in its entirety.
- The partitioning device preferably includes a supporting component or stem which has a length configured to extend distally to the heart wall surface to support the partitioning device within the heart chamber. In an embodiment, the supporting component has a plurality of pods or feet, preferably at least three, which distribute the force of the partitioning device about a region of the ventricular wall surface to minimize, preferably avoid, immediate or long term damage to the tissue of the heart wall, particularly compromised or necrotic tissue such as tissue of a myocardial infarct (MI) and the like. Pods of the support component extend radially and preferably are interconnected by struts or planes which help distribute the force over an expanded area of the ventricular surface.
- The partitioning device may be delivered percutaneously or intraoperatively. One particularly suitable delivery catheter has an elongate shaft, a releasable securing device on a distal end of the shaft for holding the partitioning device on the shaft distal end and an expandable member such as an inflatable balloon on a distal portion of the shaft proximal to the shaft distal end to expand the interior surface of the collapsed partitioning device formed by the pressure receiving surface to effectuate the tissue penetrating tips or elements on the periphery of the partitioning device to sufficiently engage, preferably penetrate, the heart wall and to hold the partitioning device in a desired position to effectively partition the heart chamber. A suitable delivery device is described in co-pending application Ser. No. 10/913,608, filed on Aug. 5, 2004, assigned to the assignee of the present invention.
- The methods of the present invention are easy to perform and provide for a substantially improved treatment of a diseased heart. As a result of the method of the present invention, a more normal diastolic and systolic movement of a patient's diseased heart is achieved. Concomitantly, an increase in the ejection fraction of the patient's heart chamber is usually obtained. These and other advantages of the invention will become more apparent from the following detailed description of the invention and the accompanying exemplary drawings.
-
FIG. 1A is a schematic view of a patient's heart having a myocardial infarct which may exhibit characteristics of an incipient rupture in the ventricular septum. -
FIG. 1B is a schematic view of the patient's heart ofFIG. 1A with a ventricular septal defect resulting from a rupture in the heart wall. -
FIG. 1C is a schematic view of the patient's heart ofFIG. 1B after treatment according to a method of the present invention. -
FIG. 2A is a schematic view of a patient's heart exhibiting a myocardial infarct with free wall rupture of the left ventricular chamber. -
FIG. 2B is a schematic view of the patient's heart ofFIG. 2A with a left ventricular chamber tamponade. -
FIG. 2C is a schematic view of the patient's heart ofFIG. 2B after treatment according to a method of the present invention. -
FIG. 3 is an elevational view of a partitioning device embodying features of the invention in an expanded configuration. -
FIG. 4 is a plan view of the partitioning device shown inFIG. 3 illustrating the upper surface of the device. -
FIG. 5 is a bottom view of the partitioning device shown inFIG. 3 . -
FIG. 6 is a perspective view of the non-traumatic tip of the distally extending stem of the device shown inFIG. 3 . -
FIG. 7 is a partial cross-sectional view of a hub of the partitioning device shown inFIG. 4 taken along the lines 7-7. -
FIG. 8 is a transverse cross-sectional view of the hub shown inFIG. 7 taken along the lines 8-8. -
FIG. 9 is a longitudinal view, partially in section of a reinforcing rib and membrane at the periphery of the partitioning device shown inFIG. 3 . -
FIG. 10 is a schematic elevational view, partially in section, of a delivery system for the partitioning device shown inFIGS. 3 and 4 . -
FIG. 11 is a transverse cross-sectional view of the delivery system shown inFIG. 10 taken along the lines 11-11. -
FIG. 12 is an elevational view, partially in section, of the hub shown inFIG. 7 secured to a helical coil of the delivery system shown inFIG. 10 . -
FIGS. 13A-13E are schematic views of a patient's left ventricular chamber illustrating the deployment of the partitioning device shown inFIGS. 3 and 4 with the delivery system shown inFIG. 10 to partition a patient's heart chamber (e.g., left ventricle) into a primary productive portion and a secondary, non-productive portion. -
FIG. 14 is a schematic view of the patient's heart after treatment according to a method of the present invention utilizing a device embodying features of the present invention having an reinforced membrane with an eccentric peripheral base. -
FIG. 1A is a schematic illustration of a patient'sheart 10 showing theright ventricle 11 and theleft ventricle 12 with themitral valve 13 andaortic valve 14. Apericardium membrane 15 is shown surrounding theheart 10. At least a portion ofmyocardium layer 17 of theleft ventricle 12, as shown inFIG. 1A , is exhibiting an area of infarct 18 (“MI”) extending along a portion ofventricular septum wall 19 which separates the right and left ventricles and exhibits characteristics of an incipient rupture.FIG. 1B illustrates the advancing of the infarct leading to the generation of a rupture oropening 20 in theseptum wall 19, a condition referred to as VSD. As shown inFIG. 1B oxygenatedblood 21 flows directly to theright ventricle 11 through theseptum opening 20. As a result of this movement, or shunting, at least two consequences are reached, firstly, the right portion of the heart works harder pumping a greater volume of blood than it normally would, and secondly, the amount of oxygenated blood in the left ventricle is reduced leading to a lower oxygen level to the other tissues of the body.FIG. 1C illustrates theleft ventricle 12 ofFIG. 1B after it has been partitioned, with the use of apartitioning device 30 according to the present invention and as described further below, into a main productive oroperational portion 23 and a secondary, essentiallynon-productive portion 24. As can be seen fromFIG. 1C , with fluid path to the septum opening blocked or reduced, the normal flow of blood from the left ventricle to the rest of the body through the aortic valve is restored. -
FIG. 2A is a schematic illustration of the patient'sheart 10 showing theright ventricle 11 and theleft ventricle 12 with themitral valve 13 andaortic valve 14. - The
pericardium membrane 15 is shown surrounding the heart. A pericardium (pericardial complex) consists of an outer fibrous layer and an inner serous layer. Thepericardial space 16 normally contains 20-50 mL of fluid. At least a portion of themyocardium layer 17 of theleft ventricle 12, as shown inFIG. 2A , is exhibiting the area of infarct 18 (“MI”) extending along a portion of theleft ventricle 12 resulting in the free wall rupture oropening 20 leading to a movement ofblood 21 from the left ventricle into thepericardial space 16. -
FIG. 2B illustrates the advancing of the infarct leading to the rupture oropening 20 increasing in size. As shown inFIG. 2B , the flow of theblood 21 into thepericardial space 16 increases over time leading to a greater accumulation of blood in the pericardial space. This movement and accumulation of blood in the pericardial space, a condition referred to as ventricular tamponade, results in reduced ventricular filling and subsequent hemodynamic compromise.FIG. 2C illustrates theleft ventricle 12 ofFIG. 2B after it has been partitioned, with the use of thepartitioning device 30 according to the present invention, into the main productive oroperational portion 23 and the secondary, essentiallynon-productive portion 24. As can be seen fromFIG. 1C , with fluid path to the pericardial space blocked or reduced, the normal flow of blood from the left ventricle to the rest of the body through the aortic valve is restored. -
FIGS. 3-6 illustrate thepartitioning device 30 which embodies features of the invention and which may be utilized in practicing the method of the present invention. Thedevice 30 includes apartitioning membrane 31, ahub 32, preferably centrally located on the partitioning device, and a radially expandable reinforcingframe 33 formed of a plurality ofribs 34. Preferably, at least part of thepartitioning membrane 31 is secured to a proximal orpressure receiving side 35 of theframe 33 as shown inFIG. 3 . Theribs 34 have distal ends 36 which are secured to thehub 32, and free proximal ends 37 which are configured to curve or flare away from acenter line axis 38 at least upon expansion of the partitioning device. Radial expansion of the free proximal ends 37 unfurls themembrane 31 secured to theframe 33 so that the membrane presents thepressure receiving surface 35 which defines in part theproductive portion 23 of the patient's partitioned heart chamber, as discussed with reference toFIGS. 1A-1C and 2A-2C. A peripheral edge 39 of themembrane 31 may be serrated as shown. - A continuous
expansive strand 40 extends around the periphery of themembrane 31 on thepressure receiving side 35 thereof to apply pressure to the pressure side of the flexible material of the membrane to effectively seal the periphery of the membrane against the wall of the ventricular chamber. Ends 41 and 42 of theexpansive strand 40 are shown extending away from the partitioning device inFIGS. 3 and 5 . The ends 41 and 42 may be left unattached or may be secured together, e.g. by a suitable adhesive, to themembrane 31 itself. While not shown in detail, themembrane 31 has a proximal layer secured to the proximal faces of theribs 34 and a distal layer secured to the distal faces of the ribs in a manner described in co-pending application Ser. No. 10/913,608, filed on Aug. 5, 2004, assigned to the assignee of the present invention, and incorporated herein by reference in its entirety. - The
hub 32 shown inFIGS. 6 and 7 preferably has adistally extending stem 43 with anon-traumatic support component 44. Thesupport component 44 has a plurality of pods orfeet 45 extending radially away from thecenter line axis 38 and the ends of thefeet 45 are secured to struts 46 which extend between adjacent feet. A plane of material (not shown) may extend betweenadjacent feet 45 in a web-like fashion to provide further support in addition to or in lieu of thestruts 46. - As shown in
FIG. 7 , the distal ends 36 of theribs 34 are secured within thehub 32 and, as shown inFIG. 8 , a transversely disposedconnector bar 47 is secured within the hub which is configured to secure thehub 32 and thus thepartitioning device 30 to a delivery system such as that shown inFIGS. 10-12 . -
FIG. 9 illustrates the curved free proximal ends 37 ofribs 34 which are provided withsharp tip elements 48 configured to engage, and preferably penetrate into, the wall of the heart chamber and hold thepartitioning device 30 in a deployed position within the patient's heart chamber so as to partition the ventricular chamber into a productive portion and a non-productive portion, as described above with reference toFIGS. 1A-1C and 2A-2C. - The
connector bar 47 of thehub 32, as will be described later, allows thepartitioning device 30 to be connected to thenon-traumatic component 44 which can be secured to a delivery catheter for delivery and to be released from the delivery system within the patient's heart chamber. The distal ends 36 of the reinforcingribs 34 are secured within thehub 32 in a suitable manner or they may be secured to the surface defining the inner lumen of the hub or they may be disposed within channels or bores in the wall of thehub 32. Thedistal end 36 of theribs 34 are preshaped so that when the ribs are not constrained, other than by themembrane 31 secured thereto (as shown inFIGS. 3 and 4 ), the free proximal ends 37 thereof expand to a desired angular displacement, away from thecenterline axis 38, of about 20° (degree) to about 90°, preferably about 50° to about 80°. The unconstrained diameter of thepartitioning device 30 is preferably greater than the diameter of the heart chamber at the deployed location of the partitioning device so that an outward force is applied to the wall of the heart chamber by the at least partially expandedribs 34 during systole and diastole so that theresilient frame 33 augments the heart wall movement. -
FIGS. 10-12 illustrate onesuitable delivery system 50 delivering thepartitioning device 30, shown inFIGS. 3 and 4 ; into a patient's heart chamber and deploying the partitioning device to partition the heart chamber as shown inFIGS. 13A-13E . Thedelivery system 50 includes aguide catheter 51 and adelivery catheter 52. For purposes of clarity, as shown inFIGS. 13A-13E , the heart chamber is shown without rupture or openings 20 (as shown inFIGS. 1A-1C andFIGS. 2A-2C ). The present invention may be practiced after the myocardial infarct has lead to the creation of rupture or openings (such as 20) in the heart chamber, or in the case of an incipient rupture, prior to the creation of the rupture or openings as a means to minimize the size and/or the effects of rupture or opening. - The
guide catheter 51 has aninner lumen 53 extending between proximal and distal ends, 54 and 55. Aflush port 57 on theproximal end 54 ofguide catheter 51 is in fluid communication with theinner lumen 53 for injecting therapeutic or diagnostic fluids thereto. - The
delivery catheter 52 has anouter shaft 58 with an interior 59, and anadapter 60 at a proximal end thereof with aproximal injection port 61 which is fluid communication withinterior 59 for injecting therapeutic or diagnostic fluids thereto. A hemostatic valve (not shown) may be provided at theproximal end 54 of theguide catheter 51 to seal about theouter shaft 58 of thedelivery catheter 52. - As shown in more detail in
FIG. 11 , theouter shaft 58 has aninner shaft 62 with an interior 63, and is disposed within theinterior 59 of the outer shaft and is secured to aninner surface 64 of theouter shaft 58 bywebs 65 which extend along a substantial length of theinner shaft 62. Thewebs 65 define inpart passageways 66 formed between the inner andouter shafts injection port 61 is in fluid communication withpassageways 66 for directing therapeutic and/or diagnostic fluids thereto. - A
torque shaft 67, preferably formed from hypotubing (e.g., stainless steel or superelastic NiTi) and having aninner lumen 68, is rotatably disposed within aninner lumen 69 of theinner shaft 62, and is secured at aproximal end 70 thereof within anadapter 71 with arotating knob 72. - A balloon inflation port 73, preferably proximal to the
rotating knob 72, is in fluid communication with theinner lumen 68 of thetorque shaft 67. - A
helical coil screw 74 is secured to adistal end 75 of thetorque shaft 67 and rotation of thetorque knob 72 on theproximal end 70 of thetorque shaft 67 rotates thescrew 74 on thedistal end 75 oftorque shaft 67 to facilitate deployment of thepartitioning device 30. Aninflatable balloon 76 at itsproximal end 77 is sealingly secured (e.g., by way of adhesive 78) about thetorque shaft 67 proximal to thedistal end 75 of the torque shaft and has an interior 79 in fluid communication with theinner lumen 68 of thetorque shaft 67. Inflation fluid may be delivered to the interior 79 of the balloon through port 73. Inflation of theballoon 76 by inflation fluid through port 73 facilitates securing thepartitioning device 30 to the heart wall. - As shown in
FIGS. 13A through 13E , thepartitioning device 30 is delivered through thedelivery system 50 which includes theguide catheter 51 and thedelivery catheter 52. Thepartitioning device 30 is collapsed to a first delivery configuration which has small enough transverse dimensions to be slidably advanced through theinner lumen 53 of theguide catheter 51. Preferably, theguide catheter 51 has been previously percutaneously introduced and advanced through the patent's vasculature, such as the femoral artery, in a conventional manner to the desired heart chamber, such as theleft ventricle 12. Thedelivery catheter 52 with thepartitioning device 30 attached is advanced through theinner lumen 53 of theguide catheter 51 until thepartitioning device 30 is ready for deployment from the distal end of theguide catheter 51 into the patient's heart chamber, such asleft ventricle 12, to be partitioned. - The
partitioning device 30 mounted on thescrew 74 is urged partially out of theinner lumen 53 of theguide catheter 51 until thesupport component 44 of thehub 32 engages the heart wall as shown inFIG. 13B with the free proximal ends 37 of theribs 34 in a contracted configuration within the guide catheter. The guidingcatheter 51 is withdrawn while thedelivery catheter 52 is held in place until the proximal ends 37 of theribs 34 exit adistal end 55 of the guidingcatheter 51. The free proximal ends 37 ofribs 34 expand outwardly to press the sharpproximal tips 48 of theribs 34 against and preferably into the tissue lining the heart chamber. - With the partitioning device deployed within the heart chamber and preferably partially secured therein, inflation fluid is introduced through the inflation port 73 into the
inner lumen 68 of thetorque shaft 67 and into theballoon interior 79 to inflate theballoon 76. Theinflated balloon 76 presses against thepressure receiving surface 35 of themembrane 31 of thepartitioning device 30 to ensure that the sharpproximal tips 48 are pressed well into the tissue lining the heart chamber. - With the
partitioning device 30 properly positioned within the heart chamber, theknob 72 on thetorque shaft 67 is rotated (e.g., counter-clockwise) to disengage thehelical coil screw 74 of thedelivery catheter 52 from thestem 43 of the non-traumatic support component. The counter-clockwise rotation of thetorque shaft 67 rotates thehelical coil screw 74 which rides in thestem 43 of non-traumatic support component secured within thehub 32. Once thehelical coil screw 74 disengages, thestem 43, thedelivery system 50, including theguide catheter 51 and thedelivery catheter 52, may then be removed from the patient. - The
partitioning device 30 partitions the patient's heart chamber, such asleft ventricle 12, into the main productive oroperational portion 23 and the secondary, essentiallynon-productive portion 24. Theoperational portion 23 is much smaller than the original ventricular chamber and provides for an improved ejection fraction. The partitioning increases the ejection fraction and provides an improvement in blood flow. Over time, thenon-productive portion 24 may fill first with thrombus and subsequently with cellular growth. Bio-resorbable fillers such as polylactic acid, polyglycolic acid, polycaprolactone and copolymers and blends thereof may be employed to initially fill thenon-productive portion 24. Fillers may be suitably supplied in a suitable solvent such as dimethylsulfoxide (DMSO). Other materials which accelerate tissue growth or thrombus may be deployed in thenon-productive portion 24 as well as non-reactive fillers. It should be noted that although the present figures describe the treatment of the left ventricle, the same can be applied to other chambers of the heart. -
FIG. 14 illustrates an alternative design which embodies features of a device usable in practicing methods having features of the present invention, in which thepartitioning device 30′ is provided with an eccentric-shapedmembrane 31′ which is well suited for treating VSD lesions that may occur further up (more proximal) the ventricular septum because of the different anatomical features and physiologic action of the ventricular septum versus the anterior free wall. The septal wall primarily moves in and out only, relative to the chamber, versus the free wall that has a rotation component to its excursion. Secondly, the outflow track which comprises the upper half of the ventricular septal wall below the aortic valve has very little or no trebeculation. It is particularly well suited for placement of the device placed to address necrotic failure of the tissue of the ventricular septum. In the embodiment shown inFIG. 14 , the device is shown with anubbin foot 45′ (and not the extended stem foot) allowing the device to sit more distally and intimately with the apex. - The details of the
partitioning device 30′ are essentially the same as in the previous embodiments and elements in this alternative embodiment are given the same reference numbers but primed as similar elements in the previously discussed embodiments. Thepartitioning device 30′ forms a conical shape as in the previously discussed embodiments but the peripheral base of the conical shape which engages the wall that has a first dimension in a first direction greater than a second dimension in a second direction. Preferably, the second direction is at a right angle with respect to the first direction. The lengths of theribs 34′ are adjusted to provide the desired shape to the periphery of the device which engages the interior of the heart chamber. - The partitioning device 30 (and 31′) may be conveniently formed by the method described in co-pending application Ser. No. 10/913,608 assigned to the assignee of the present invention and which is incorporated herein by reference in its entirety.
- While porous ePTFE material is preferred, the
membrane 31 may be formed of suitable biocompatible polymeric material which includes Nylon, PET (polyethylene terephthalate) and polyesters such as Hytrel. Themembrane 31 is preferably foraminous in nature to facilitate tissue ingrowth after deployment within the patient's heart. Thedelivery catheter 52 and the guidingcatheter 51 may be formed of suitable high strength polymeric material such as PEEK (polyetheretherketone), polycarbonate, PET, Nylon, and the like. Braided composite shafts may also be employed. - To the extent not otherwise described herein, the various components of the partitioning device and delivery system may be formed of conventional materials and in a conventional manner as will be appreciated by those skilled in the art.
- While particular forms of the invention have been illustrated and described herein, it will be apparent that various modifications and improvements can be made to the invention. Moreover, individual features of embodiments of the invention may be shown in some drawings and not in others, but those skilled in the art will recognize that individual features of one embodiment of the invention can be combined with any or all the features of another embodiment. Accordingly, it is not intended that the invention be limited to the specific embodiments illustrated. It is intended that this invention to be defined by the scope of the appended claims as broadly as the prior art will permit.
- Terms such a “element,” “member,” “component,” “device,” “section,” “portion,” “step,” “means,” and words of similar import, when used herein shall not be construed as invoking the provisions of 35 U.S.C. §112(6) unless the following claims expressly use the term “means” followed by a particular function without specific structure or the term “step” followed by a particular function without specific action. Accordingly, it is not intended that the invention be limited, except as by the appended claims. All patents and patent applications referred to herein are hereby incorporated by reference in their entirety.
Claims (39)
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US11/199,633 US20060229491A1 (en) | 2002-08-01 | 2005-08-09 | Method for treating myocardial rupture |
ES06800894.5T ES2556181T3 (en) | 2005-08-09 | 2006-08-07 | Implant for the treatment of myocardial rupture |
EP06800894.5A EP1922023B1 (en) | 2005-08-09 | 2006-08-07 | Implant for treating myocardial rupture |
AU2006280120A AU2006280120B2 (en) | 2005-08-09 | 2006-08-07 | Method for treating myocardial rupture |
CA2617949A CA2617949C (en) | 2005-08-09 | 2006-08-07 | Method for treating myocardial rupture |
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JP2008526109A JP2009504255A (en) | 2005-08-09 | 2006-08-07 | How to treat myocardial rupture |
US12/129,443 US8529430B2 (en) | 2002-08-01 | 2008-05-29 | Therapeutic methods and devices following myocardial infarction |
US12/893,832 US9078660B2 (en) | 2000-08-09 | 2010-09-29 | Devices and methods for delivering an endocardial device |
US13/973,868 US8827892B2 (en) | 2002-08-01 | 2013-08-22 | Therapeutic methods and devices following myocardial infarction |
US14/448,778 US9592123B2 (en) | 2002-08-01 | 2014-07-31 | Therapeutic methods and devices following myocardial infarction |
US14/731,161 US20150265405A1 (en) | 2000-08-09 | 2015-06-04 | Devices and methods for delivering an endocardial device |
US15/133,080 US10064696B2 (en) | 2000-08-09 | 2016-04-19 | Devices and methods for delivering an endocardial device |
US15/452,435 US10307147B2 (en) | 1999-08-09 | 2017-03-07 | System for improving cardiac function by sealing a partitioning membrane within a ventricle |
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Also Published As
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WO2007021647A3 (en) | 2008-10-02 |
JP2009504255A (en) | 2009-02-05 |
CA2617949A1 (en) | 2007-02-22 |
EP1922023B1 (en) | 2015-10-14 |
ES2556181T3 (en) | 2016-01-13 |
EP1922023A2 (en) | 2008-05-21 |
AU2006280120A1 (en) | 2007-02-22 |
EP1922023A4 (en) | 2012-06-20 |
AU2006280120B2 (en) | 2012-06-21 |
WO2007021647A2 (en) | 2007-02-22 |
CA2617949C (en) | 2013-11-19 |
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